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Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
Chrysler (FCA US, LLC) is recalling certain 2020-2023 Ram 1500 Classic vehicles equipped with heated trailer tow rearview mirrors. The mirror glass may detach from the driver's side heated trailer tow rearview mirror. As such these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 111, "Rear Visibility."
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.